This trial is completed!
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You can access this
clinical trial
if you have
Cardiac Surgical Procedures or Cardiopulmonary Bypass
and you are
over 18
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise (vasodilatation plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction is a major adverse complication after CPB surgery. Investigators hypothesize that the use of an increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical complexity. The safe use of OXIRIS® will reduce both cytokine circulatory levels and lipopolysaccharide (LPS) circulatory levels therefore decreasing SIRS and its systemic effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®) could potentially present less postcardiac surgery acute kidney injury (pAKI), lower intensive care unit (ICU) and hospital length of stay, and lower production of renal injury biomarkers (cell-cycle-arrest-proteins) tissue inhibitor of metalloproteinase-2 (TIMP-2) and insulin growth factor binding protein-7 (IGFBP-7).

Provided treatments

  • Device: OXIRIS®
Tris trial is registered with FDA with number: NCT02398019. The sponsor of the trial is Hospital Universitari de Bellvitge and it is looking for 20 volunteers for the current phase.
Official trial title:
Clinical Trial to Evaluate Facticity and Security for the Use of an Increased Adsorption Capacity Membrane (OXIRIS®) During Cardiopulmonary Bypass Surgery